Corning 925 Chloride Meter
FDA 510(k) K810615 · Corning Medical & Scientific
510(k) numberK810615
Submission
- Device name
- Corning 925 Chloride Meter
- Applicant
- Corning Medical & Scientific
Mchenry, IL, US - Received
- March 9, 1981
- Decision date
- March 17, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JFS – Coulometric, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121823 | Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer…JFS · Traditional | Wescor, Inc. | 03/27/2013SE |
| K923598 | Redi-Check Photmeter Q.A.JFS · Traditional | Awareness Technology, Inc. | 10/14/1992SE |
| K873127 | Chloride Reagent KitJFS · Traditional | A-Kem, Inc. | 10/23/1987SE |
| K830217 | Reagents Corning Chloride Meter forJFS · Traditional | Fisher Scientific Co., LLC | 02/18/1983SE |
| K823106 | Rermco Test Chloride ReagentJFS · Traditional | Fermco Biochemics, Inc. | 11/16/1982SE |
| K820411 | Liquizyme Chloride ReagentJFS · Traditional | American Research Products Co. | 03/08/1982SE |
| K811319 | Chloride Reagent KitJFS · Traditional | Chem-Elec, Inc. | 08/13/1981SE |
| K811701 | Chloride/Carbon Dioxide Rate ReagentJFS · Traditional | Chem-Elec, Inc. | 07/01/1981SE |
| K810550 | Silver AnodeJFS · Traditional | Nobel Scientific Industries, Inc. | 04/08/1981SE |
| K802080 | Baker Diag. Ultrarate Chloride KitJFS · Traditional | J.T. Baker Chemical Co. | 10/10/1980SE |
More from J.T. Baker Chemical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K875122 | Disposable Sterile Syringe FiltersKET · Traditional | 01/12/1988SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | 07/07/1987SE |
| K872076 | Corning Disposable Roller BottlesKJB · Traditional | 06/15/1987SE |
| K863789 | Corning Elisa PlatesLIB · Traditional | 10/03/1986SE |
| K854024 | Corning Magic Mab HCG RadioimmunoassayJHI · Traditional | 11/26/1985SE |
| K853634 | Corning Cell Wells-Multiple Well PlatesKIZ · Traditional | 09/16/1985SE |
| K851939 | Corning Certain -IseJIX · Traditional | 06/14/1985SE |
| K851329 | Magic Monoclonal Antibody Tsh(Mab Tsh)RadioimmunoaJLW · Traditional | 06/13/1985SE |
| K850806 | Corning Blood Collection Capillary TubesGIO · Traditional | 03/25/1985SE |
| K850617 | Corning 780 Fluorometer/DensitometerJQT · Traditional | 03/12/1985SE |
Questions and answers
When was Corning 925 Chloride Meter cleared by the FDA?
Corning 925 Chloride Meter (K810615) received a 510(k) decision of Substantially Equivalent on March 17, 1981, 8 days after the submission was received.
What is the product code of K810615?
The FDA product code is JFS – Coulometric, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.